Just days af­ter the World Health Or­ga­ni­za­tion sus­pend­ed the use of Co­v­ax­in af­ter a man­u­fac­tur­ing site failed an in­spec­tion, the FDA has fol­lowed up with a clin­i­cal hold on the Covid-19 vac­cine’s US co-de­vel­op­er.

De­tails are in short sup­ply, but the man­u­fac­tur­ing site run by Bharat Biotech in In­dia is at the cen­ter of the is­sue af­ter be­ing cit­ed for “de­fi­cien­cies.” On Tues­day morn­ing, Bharat Biotech’s part­ner Ocu­gen re­port­ed US reg­u­la­tors had placed a hold on the shot’s Phase II/III study. Bharat Biotech de­vel­oped the shot and li­censed it to Ocu­gen to co-de­vel­op it in the US and Cana­da.

At the start of April, the World Health Or­ga­ni­za­tion sus­pend­ed its sup­ply of Co­v­ax­in, known in the US as BBV-152, through the Unit­ed Na­tions, af­ter in­spec­tors took is­sue with the In­di­an man­u­fac­tur­ing fa­cil­i­ties of Bharat Biotech.

“This is a re­sult of the com­pa­ny’s de­ci­sion to vol­un­tar­i­ly im­ple­ment a tem­po­rary pause in dos­ing par­tic­i­pants of OCU-002 while it eval­u­ates state­ments made by the World Health Or­ga­ni­za­tion fol­low­ing their in­spec­tion of Bharat Biotech In­ter­na­tion­al Lim­it­ed’s man­u­fac­tur­ing fa­cil­i­ty,” Ocu­gen said in a state­ment. “We will work with the FDA to ad­dress any ques­tions.”

An in­ac­ti­vat­ed virus-based vac­cine, Co­v­ax­in has been in use in In­dia since ear­ly 2021. It’s al­so been au­tho­rized in about a dozen oth­er coun­tries — and the WHO en­dorsed it for emer­gency use late last year. Based on Phase III da­ta from In­dia, un­veiled in June, the shot was al­most 78% ef­fec­tive at pre­vent­ing dis­ease.

Ocu­gen has long planned a Phase II/III im­muno­bridg­ing and boost­er tri­al in the US in or­der to bring it state­side. But in No­vem­ber, the FDA is­sued a clin­i­cal hold on the IND, with few de­tails re­leased. That was lift­ed in Feb­ru­ary.

It al­so sub­mit­ted a re­quest to the FDA for emer­gency use in chil­dren above the age of 2 in No­vem­ber, but the re­quest was de­nied in March.

But just a few days ago, the WHO sus­pend­ed the sup­ply of Co­v­ax­in from the UN un­til “ap­pro­pri­ate ac­tions” were tak­en to ad­dress man­u­fac­tur­ing prac­tices that weren’t up to code with cur­rent GMP stan­dards. The WHO did clar­i­fy that there were no safe­ty or ef­fi­ca­cy is­sues with the vac­cine.

That an­nounce­ment fol­lowed just a day af­ter Bharat said it would scale back pro­duc­tion of the vac­cine, fol­low­ing a de­crease in de­mand that co­in­cid­ed with a re­duced num­ber of in­fec­tions and hos­pi­tal­ized pa­tients.

Bharat had al­ready turned to oth­er vac­cine mak­ers — such as an­i­mal vac­cine mak­er Hes­ter Bio­sciences — to help ramp up pro­duc­tion at the start of its ef­forts.

Ocu­gen’s stock $OCGN sank 9% on the news in No­vem­ber, but bounced back al­most 7% in pre-mar­ket trad­ing days lat­er.

Shares were trad­ing around $2.72 Tues­day morn­ing, down about $1 from about a month ago. That’s a far cry away from the high of $15.67 in which it was trad­ing be­fore the first clin­i­cal hold in No­vem­ber.

A handful of CDMOs have made changes at the top over the past few weeks, including Genezen and Curia.

That also includes Australian CDMO BioCina, which announced last week that Mark Womack would be taking the helm. Womack previously served as chief business officer at AGC Biologics, CEO of Indian manufacturer Stelis Biopharma and most recently, CEO at CDMO KBI Biopharma and Selexis SA.

BioCina completed the takeover of a Pfizer manufacturing facility in Adelaide in 2021 and is now prepping for wider growth. Endpoints News sat down with Womack to discuss his new role, plans for the future, and how to compete in the wider CDMO market. This interview has been edited for brevity and clarity.

Digital therapeutics company Better Therapeutics announced on Thursday that it’s cutting 35% of its staff as it awaits FDA clearance for its first product.

The company, which launched eight years ago, is one of a growing group of companies seeking a digital alternative to traditional medicine. The space saw a record $7.5 billion in investments in 2021, according to Chris Dokomajilar at DealForma, with uses spanning ADHD, PTSD and other indications. However, private insurers have been slow to hop on board.

The FDA’s Oncology Center of Excellence has been a bright spot within the agency in terms of speeding new treatments to patients. That flexibility was on full display this morning as FDA released new draft guidance spelling out exactly how oncology drug developers can fulfill both the accelerated and full approval’s requirements with just a single randomized controlled trial.

While Congress recently passed legislation that will allow FDA to require confirmatory trials to be recruiting and ongoing prior to granting an accelerated approval, the agency is now making clear that the initial trial used to win the AA, if designed appropriately, can also serve as the trial for converting the accelerated approval into a full approval.